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To evaluate whether postoperative PROM scores of spine patients are influenced by memory bias
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | no recall PROMs group ; without knowledge of previous PROMs scores | |
| intervention group | Active Comparator | recall PROMs group ; with knowledge of previous PROMs scores |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROMs | Behavioral | evaluate the impact of recall bias on post proms scores |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median COMI score results | Core outcome measures index. Scale 0 to 10 where 0 means the best score | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Median ODI score | Neck disability index Oswestry disability index. Scale 0 to 100 where 0 means the worst score | 4 weeks |
| Median EQ-5D score | EuroQol 5 D where 1 is the best score and -0,500 the worst score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar Universitário São João | Porto | Portugal | ||||
| Centro Hospitalar Universitário São João |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2021 | Apr 28, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2021 | Apr 28, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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patients are unaware whether they are in the intervention or control group
| 4 weeks |
| Median NDI | Neck disability index Scale 0 to 100 where 0 means the worst score | 4 weeks |
| Portugal |
| Portugal |